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Browse Drug Recalls

515 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 515 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 515 FDA drug recalls.

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DateProductReasonClassFirm
Jul 12, 2018 Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distr... Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. Class II Sun Pharmaceutical Industries, Inc.
Jul 2, 2018 Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Do... Presence of Particulate Matter: identified as glass and silicone material Class I AuroMedics Pharma LLC
Jun 4, 2018 Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Si... Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. Class I HOSPIRA INC, LAKE FOREST
May 1, 2018 Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intr... Presence of Particulate Matter: confirmed customer report for presence of visible particulate mat... Class I AuroMedics Pharma LLC
May 1, 2018 Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular... Presence of Particulate Matter: confirmed customer report of the presence of visible particulate ... Class I AuroMedics Pharma LLC
Apr 5, 2018 CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C B... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.,... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., S... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bio... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Feb 16, 2018 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PI... Presence of Particulate Matter: Customer complaint of particulate matter which has been identifie... Class II B. Braun Medical Inc
Jan 12, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U... Presence of Particulate Matter; contains visible particulate matter identified as mold. Class I AuroMedics Pharma LLC
Jan 2, 2018 Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for in... Presence of Particulate Matter: A confirmed customer report was received for the presence of visi... Class I Aurobindo Pharma Ltd.
Dec 20, 2017 Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use ... Presence of Particulate Matter; white particulate matter identified as mold was found in one bag Class I AuroMedics Pharma LLC
Dec 15, 2017 Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distribut... Presence of particulate matter Class II Amneal Pharmaceuticals
Dec 15, 2017 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), ... Presence of Particulate Matter: identified as polyethylene, which is consistent with the material... Class II B. Braun Medical Inc
Dec 4, 2017 Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only,... Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) ... Class I AuroMedics Pharma LLC
Nov 10, 2017 Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx O... Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of... Class I Baxter Healthcare Corporation
Sep 13, 2017 Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1... Presence of particulate matter: glass flakes identified as lamellae observed during a routine qua... Class II Amgen, Inc.
Aug 31, 2017 Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Si... Presence of Particulate Matter Class II Amneal Pharmaceuticals LLC
Aug 30, 2017 Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only... Presence of Particulate Matter: glass particulate found in vial Class I Pfizer Inc.
Aug 22, 2017 Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-... Crystallization: Product is being recalled due to the manufacturer's recall due to the presence o... Class II RemedyRepack Inc.
Aug 15, 2017 Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose ... Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of re... Class II Amphastar Pharmaceuticals, Inc.
Aug 4, 2017 Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subc... Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product ... Class II Amgen, Inc.
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Singl... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST
Jul 26, 2017 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container... Presence of Particulate Matter; stainless steel Class II ICU Medical Inc
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST
Apr 28, 2017 Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-... Crystallization: due to the presence of white, crystalline particulates, adhered to the side and ... Class II PAR Sterile Products LLC
Apr 21, 2017 Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Sing... Presence of Particulate Matter: human hair found within an internal sample syringe. Class I Hospira Inc.
Mar 17, 2017 Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, D... Presence of Particulate Matter: Glass Class II Shire
Mar 15, 2017 Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramusc... Presence of Particulate Matter Class II Sun Pharmaceutical Industries, Inc.
Feb 8, 2017 Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC... Presence of Particulate Matter Class I X-Gen Pharmaceuticals Inc.
Feb 3, 2017 Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Onl... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume ... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, ... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, S... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Onl... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, R... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Jan 24, 2017 Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package ... Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. Th... Class I Hospira Inc., A Pfizer Company
Aug 15, 2016 DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be ... Discoloration: Firm received complaints of product discoloration and particulates. Class II Hospira Inc.
Aug 4, 2016 Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Sing... Presence of particulate matter: Confirmed customer report for the presence of particulate matter ... Class I Hospira Inc., A Pfizer Company
Jun 23, 2016 Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake ... Crystallization: Product contains particulate identified to be crystallized active ingredient. Class II Hospira Inc.
Jun 13, 2016 Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - ... Presence of Particulate Matter; The firm received two product complaints for small, dark particul... Class II Sagent Pharmaceuticals Inc

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.